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Article ; Online: Liraglutide for the treatment of type 2 diabetes.

Shyangdan, D / Cummins, E / Royle, P / Waugh, N

Health technology assessment (Winchester, England)

2011 Volume 15 Suppl 1, Page(s) 77–86

Abstract: This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of liraglutide in the treatment of type 2 diabetes mellitus, based upon the manufacturer's submission to the National Institute ...

Abstract	This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of liraglutide in the treatment of type 2 diabetes mellitus, based upon the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The manufacturer proposed the use of liraglutide as a second or third drug in patients with type 2 diabetes whose glycaemic control was unsatisfactory with metformin, with or without a second oral glucose-lowering drug. The submission included six manufacturer-sponsored trials that compared the efficacy of liraglutide against other glucose-lowering agents. Not all of the trials were relevant to the decision problem. The most relevant were Liraglutide Effects and Actions in Diabetes 5 (LEAD-5) (liraglutide used as part of triple therapy and compared against insulin glargine) and LEAD-6 [liraglutide in triple therapy compared against another glucagon-like peptide-1 agonist, exenatide]. Five of the six trials were published in full and one was then unpublished. Two doses of liraglutide, 1.2 and 1.8 mg, were used in some trials, but in the two comparisons in triple therapy, against glargine and exenatide, only the 1.8-mg dose was used. Liraglutide in both doses was found to be clinically effective in lowering blood glucose concentration [glycated haemoglobin (HbA1c)], reducing weight (unlike other glucose-lowering agents, such as sulphonylureas, glitazones and insulins, which cause weight gain) and also reducing systolic blood pressure (SBP). Hypoglycaemia was uncommon. The ERG carried out meta-analyses comparing the 1.2- and 1.8-mg doses of liraglutide, which suggested that there was no difference in control of diabetes, and only a slight difference in weight loss, insufficient to justify the extra cost. The cost-effectiveness analysis was carried out using the Center for Outcomes Research model. The health benefit was reported as quality-adjusted life-years (QALYs). The manufacturer estimated the cost-effectiveness to be £ 15,130 per QALY for liraglutide 1.8 mg compared with glargine, £ 10,054 per QALY for liraglutide 1.8 mg compared with exenatide, £ 10,465 per QALY for liraglutide 1.8 mg compared with sitagliptin, and £ 9851 per QALY for liraglutide 1.2 mg compared with sitagliptin. The ERG conducted additional sensitivity analyses and concluded that the factors that carried most weight were: in the comparison with glargine, the direct utility effects of body mass index (BMI) changes and SBP, with some additional contribution from HbA1c, in the comparison with exenatide, HbA1c, with some additional effects from cholesterol and triglycerides in the comparison with sitagliptin, HbA1c and direct utility effects of BMI changes. The European Medicines Agency has approved liraglutide in dual therapy with other oral glucose-lowering agents. NICE guidance recommends the use of liraglutide 1.2 mg in triple therapy when glycaemic control remains or becomes inadequate with a combination of two oral glucose-lowering drugs. The use of liraglutide 1.2 mg in a dual therapy is indicated only in patients who are intolerant of, or have contraindications to, three oral glucose-lowering drugs. The use of liraglutide 1.8 mg was not approved by NICE. The ERG recommends research into the (currently unlicensed) use of liraglutide in combination with long-acting insulin.
MeSH term(s)	Clinical Trials, Phase III as Topic ; Cost-Benefit Analysis ; Diabetes Mellitus, Type 2/drug therapy ; Drug Therapy, Combination ; Glucagon-Like Peptide 1/administration & dosage ; Glucagon-Like Peptide 1/analogs & derivatives ; Glucagon-Like Peptide 1/economics ; Glucagon-Like Peptide 1/therapeutic use ; Glycated Hemoglobin A ; Humans ; Hypoglycemic Agents/administration & dosage ; Hypoglycemic Agents/economics ; Hypoglycemic Agents/therapeutic use ; Liraglutide ; Meta-Analysis as Topic ; Metformin/therapeutic use ; Multicenter Studies as Topic ; Quality-Adjusted Life Years ; Randomized Controlled Trials as Topic ; Weight Loss
Chemical Substances	Glycated Hemoglobin A ; Hypoglycemic Agents ; Liraglutide (839I73S42A) ; Glucagon-Like Peptide 1 (89750-14-1) ; Metformin (9100L32L2N)
Language	English
Publishing date	2011-05
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2006765-3
ISSN	2046-4924 ; 1366-5278
ISSN (online)	2046-4924
ISSN	1366-5278
DOI	10.3310/hta15suppl1/09
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Article ; Online: Pan-retinal photocoagulation and other forms of laser treatment and drug therapies for non-proliferative diabetic retinopathy: systematic review and economic evaluation.

Royle, Pamela / Mistry, Hema / Auguste, Peter / Shyangdan, Deepson / Freeman, Karoline / Lois, Noemi / Waugh, Norman

Health technology assessment (Winchester, England)

2015 Volume 19, Issue 51, Page(s) v–xxviii, 1–247

Abstract: Background: Diabetic retinopathy is an important cause of visual loss. Laser photocoagulation preserves vision in diabetic retinopathy but is currently used at the stage of proliferative diabetic retinopathy (PDR).: Objectives: The primary aim was to ...

Abstract	Background: Diabetic retinopathy is an important cause of visual loss. Laser photocoagulation preserves vision in diabetic retinopathy but is currently used at the stage of proliferative diabetic retinopathy (PDR). Objectives: The primary aim was to assess the clinical effectiveness and cost-effectiveness of pan-retinal photocoagulation (PRP) given at the non-proliferative stage of diabetic retinopathy (NPDR) compared with waiting until the high-risk PDR (HR-PDR) stage was reached. There have been recent advances in laser photocoagulation techniques, and in the use of laser treatments combined with anti-vascular endothelial growth factor (VEGF) drugs or injected steroids. Our secondary questions were: (1) If PRP were to be used in NPDR, which form of laser treatment should be used? and (2) Is adjuvant therapy with intravitreal drugs clinically effective and cost-effective in PRP? Eligibility criteria: Randomised controlled trials (RCTs) for efficacy but other designs also used. Data sources: MEDLINE and EMBASE to February 2014, Web of Science. Review methods: Systematic review and economic modelling. Results: The Early Treatment Diabetic Retinopathy Study (ETDRS), published in 1991, was the only trial designed to determine the best time to initiate PRP. It randomised one eye of 3711 patients with mild-to-severe NPDR or early PDR to early photocoagulation, and the other to deferral of PRP until HR-PDR developed. The risk of severe visual loss after 5 years for eyes assigned to PRP for NPDR or early PDR compared with deferral of PRP was reduced by 23% (relative risk 0.77, 99% confidence interval 0.56 to 1.06). However, the ETDRS did not provide results separately for NPDR and early PDR. In economic modelling, the base case found that early PRP could be more effective and less costly than deferred PRP. Sensitivity analyses gave similar results, with early PRP continuing to dominate or having low incremental cost-effectiveness ratio. However, there are substantial uncertainties. For our secondary aims we found 12 trials of lasers in DR, with 982 patients in total, ranging from 40 to 150. Most were in PDR but five included some patients with severe NPDR. Three compared multi-spot pattern lasers against argon laser. RCTs comparing laser applied in a lighter manner (less-intensive burns) with conventional methods (more intense burns) reported little difference in efficacy but fewer adverse effects. One RCT suggested that selective laser treatment targeting only ischaemic areas was effective. Observational studies showed that the most important adverse effect of PRP was macular oedema (MO), which can cause visual impairment, usually temporary. Ten trials of laser and anti-VEGF or steroid drug combinations were consistent in reporting a reduction in risk of PRP-induced MO. Limitation: The current evidence is insufficient to recommend PRP for severe NPDR. Conclusions: There is, as yet, no convincing evidence that modern laser systems are more effective than the argon laser used in ETDRS, but they appear to have fewer adverse effects. We recommend a trial of PRP for severe NPDR and early PDR compared with deferring PRP till the HR-PDR stage. The trial would use modern laser technologies, and investigate the value adjuvant prophylactic anti-VEGF or steroid drugs. Study registration: This study is registered as PROSPERO CRD42013005408. Funding: The National Institute for Health Research Health Technology Assessment programme.
MeSH term(s)	Cost-Benefit Analysis ; Diabetic Retinopathy/drug therapy ; Diabetic Retinopathy/surgery ; Humans ; Laser Coagulation/economics ; Laser Coagulation/methods ; Models, Economic ; Steroids/economics ; Steroids/therapeutic use ; Vascular Endothelial Growth Factor A/antagonists & inhibitors
Chemical Substances	Steroids ; Vascular Endothelial Growth Factor A
Language	English
Publishing date	2015-07
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2006765-3
ISSN	2046-4924 ; 1366-5278
ISSN (online)	2046-4924
ISSN	1366-5278
DOI	10.3310/hta19510
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Drug treatment of macular oedema secondary to central retinal vein occlusion: a network meta-analysis.

Ford, John A / Shyangdan, Deepson / Uthman, Olalekan A / Lois, Noemi / Waugh, Norman

BMJ open

2014 Volume 4, Issue 7, Page(s) e005292

Abstract: Objective: To indirectly compare aflibercept, bevacizumab, dexamethasone, ranibizumab and triamcinolone for treatment of macular oedema secondary to central retinal vein occlusion using a network meta-analysis (NMA).: Design nma data sources: The ... ...

Abstract	Objective: To indirectly compare aflibercept, bevacizumab, dexamethasone, ranibizumab and triamcinolone for treatment of macular oedema secondary to central retinal vein occlusion using a network meta-analysis (NMA). Design nma data sources: The following databases were searched from January 2005 to March 2013: MEDLINE, MEDLINE In-process, EMBASE; CDSR, DARE, HTA, NHSEED, CENTRAL; Science Citation Index and Conference Proceedings Citation Index-Science. Eligibility criteria for selecting studies: Only randomised controlled trials assessing patients with macular oedema secondary to central retinal vein occlusion were included. Studies had to report either proportions of patients gaining ≥3 lines, losing ≥3 lines, or the mean change in best corrected visual acuity. Two authors screened titles and abstracts, extracted data and undertook risk of bias assessment. Bayesian NMA was used to compare the different interventions. Results: Seven studies, assessing five drugs, were judged to be sufficiently comparable for inclusion in the NMA. For the proportions of patients gaining ≥3 lines, triamcinolone 4 mg, ranibizumab 0.5 mg, bevacizumab 1.25 mg and aflibercept 2 mg had a higher probability of being more effective than sham and dexamethasone. A smaller proportion of patients treated with triamcinolone 4 mg, ranibizumab 0.5 mg or aflibercept 2 mg lost ≥3 lines of vision compared to those treated with sham. Patients treated with triamcinolone 4 mg, ranibizumab 0.5 mg, bevacizumab 1.25 mg and aflibercept 2 mg had a higher probability of improvement in the mean best corrected visual acuity compared to those treated with sham injections. Conclusions: We found no evidence of differences between ranibizumab, aflibercept, bevacizumab and triamcinolone for improving vision. The antivascular endothelial growth factors (VEGFs) are likely to be favoured because they are not associated with steroid-induced cataract formation. Aflibercept may be preferred by clinicians because it might require fewer injections. Systematic review registration: Not registered.
MeSH term(s)	Humans ; Macular Edema/drug therapy ; Macular Edema/etiology ; Randomized Controlled Trials as Topic ; Retinal Vein Occlusion/complications
Language	English
Publishing date	2014-07-23
Publishing country	England
Document type	Comparative Study ; Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	2599832-8
ISSN	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2014-005292
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Article ; Online: Screening for type 2 diabetes: a short report for the National Screening Committee.

Waugh, N R / Shyangdan, D / Taylor-Phillips, S / Suri, G / Hall, B

Health technology assessment (Winchester, England)

2013 Volume 17, Issue 35, Page(s) 1–90

Abstract: Background: The prevalence of type 2 diabetes mellitus (T2DM) has been increasing, owing to increases in overweight and obesity, decreasing physical activity and the changing demographic structure of the population. People can develop T2DM without ... ...

Abstract	Background: The prevalence of type 2 diabetes mellitus (T2DM) has been increasing, owing to increases in overweight and obesity, decreasing physical activity and the changing demographic structure of the population. People can develop T2DM without symptoms and up to 20% may be undiagnosed. They may have diabetic complications, such as retinopathy, by the time they are diagnosed, or may suffer a heart attack, without warning. Undiagnosed diabetes can be detected by raised blood glucose levels. Aim: The aim of this review was to provide an update for the UK National Screening Committee (NSC) on screening for T2DM. Methods: As this review was undertaken to update a previous Health Technology Assessment review published in 2007, and a more recent Scottish Public Health Network review, searches for evidence were restricted from 2009 to end of January 2012, with selected later studies added. The databases searched were MEDLINE, EMBASE, MEDLINE-in-Process & Other Non-Indexed Citations, Science Citation Index and Conference Proceedings Citation Index. The case for screening was considered against the criteria used by the NSC to assess proposed population screening programmes. Results: Population screening for T2DM does not meet all of the NSC criteria. Criterion 12, on optimisation of existing management, has not been met. A report by the National Audit Office (NAO) gives details of shortcomings. Criterion 13 requires evidence from high-quality randomised controlled trials that screening is beneficial. This has not been met. The Ely trial of screening showed no benefit. The ADDITION trial was not a trial of screening, but showed no benefit in cardiovascular outcomes from intensive management in people with screen-detected T2DM. Criterion 18 on staffing and facilities does not appear to have been met, according to the NAO report. Criterion 19 requires that all other options, including prevention, should have been considered. A large proportion of cases of T2DM could be prevented if people avoided becoming overweight or obese. The first stage of selection would use risk factors, using data held on general practitioner computer systems, using the QDiabetes Risk Score, or by sending out questionnaires, using the Finnish Diabetes Risk Score (FINDRISC). Those at high risk would have a measure of blood glucose. There is no perfect screening test. Glycated haemoglobin (HbA1c) testing has advantages in not requiring a fasting sample, and because it is a predictor of vascular disease across a wider range than just the diabetic one. However, it lacks sensitivity and would miss some people with diabetes. Absolute values of HbA1c may be more useful as part of overall risk assessment than a dichotomous 'diabetes or not diabetes' diagnosis. The oral glucose tolerance test is more sensitive, but inconvenient, more costly, has imperfect reproducibility and is less popular, meaning that uptake would be lower. Conclusions: When considered against the NSC criteria, the case for screening is less strong than it was in the 2007 review. The main reason is the absence of cardiovascular benefit in the two trials published since the previous review. There is a case for selective screening as part of overall vascular risk assessment. Population screening for T2DM does not meet all of the NSC criteria. Funding: The National Institute for Health Research Health Technology Assessment programme.
MeSH term(s)	Adult ; Age Distribution ; Aged ; Body Mass Index ; Cardiovascular Diseases/economics ; Cardiovascular Diseases/etiology ; Cardiovascular Diseases/prevention & control ; Cost-Benefit Analysis ; Diabetes Complications/economics ; Diabetes Complications/prevention & control ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/economics ; Diabetes Mellitus, Type 2/prevention & control ; Female ; Glucose Tolerance Test/economics ; Glucose Tolerance Test/standards ; Glycated Hemoglobin A/analysis ; Glycated Hemoglobin A/economics ; Humans ; Incidence ; Male ; Mass Screening/economics ; Mass Screening/methods ; Mass Screening/standards ; Metabolic Syndrome/complications ; Metabolic Syndrome/diagnosis ; Metabolic Syndrome/economics ; Metabolic Syndrome/prevention & control ; Middle Aged ; Obesity/complications ; Obesity/economics ; Prediabetic State/complications ; Prediabetic State/diagnosis ; Prediabetic State/economics ; Prevalence ; Risk Assessment ; United Kingdom
Chemical Substances	Glycated Hemoglobin A ; hemoglobin A1c protein, human
Language	English
Publishing date	2013-10-02
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2006765-3
ISSN	2046-4924 ; 1366-5278
ISSN (online)	2046-4924
ISSN	1366-5278
DOI	10.3310/hta17350
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: A systematic review of evidence on malignant spinal metastases: natural history and technologies for identifying patients at high risk of vertebral fracture and spinal cord compression.

Sutcliffe, P / Connock, M / Shyangdan, D / Court, R / Kandala, N-B / Clarke, A

Health technology assessment (Winchester, England)

2013 Volume 17, Issue 42, Page(s) 1–274

Abstract: Background: Spinal metastases can lead to significant morbidity and reduction in quality of life due to spinal cord compression (SCC). Between 5% and 20% of patients with spinal metastases develop metastatic spinal cord compression during the course of ... ...

Abstract	Background: Spinal metastases can lead to significant morbidity and reduction in quality of life due to spinal cord compression (SCC). Between 5% and 20% of patients with spinal metastases develop metastatic spinal cord compression during the course of their disease. An early study estimated average survival for patients with SCC to be between 3 and 7 months, with a 36% probability of survival to 12 months. An understanding of the natural history and early diagnosis of spinal metastases and prediction of collapse of the metastatic vertebrae are important. Objectives: To undertake a systematic review to examine the natural history of metastatic spinal lesions and to identify patients at high risk of vertebral fracture and SCC. Data sources: The search strategy covered the concepts of metastasis, the spine and adults. Searches were undertaken from inception to June 2011 in 13 electronic databases [MEDLINE; MEDLINE In-Process & Other Non-Indexed Citations; EMBASE; Cochrane Database of Systematic Reviews; Cochrane Central Register of Controlled Trials (CENTRAL); Database of Abstracts of Reviews of Effects (DARE), NHS Economic Evaluation Database (NHS EED), HTA databases (NHS Centre for Reviews and Dissemination); Science Citation Index and Conference Proceedings (Web of Science); UK Clinical Research Network (UKCRN) Portfolio Database; Current Controlled Trials; ClinicalTrials.gov]. Review methods: Titles and abstracts of retrieved studies were assessed by two reviewers independently. Disagreement was resolved by consensus agreement. Full data were extracted independently by one reviewer. All included studies were reviewed by a second researcher with disagreements resolved by discussion. A quality assessment instrument was used to assess bias in six domains: study population, attrition, prognostic factor measurement, outcome measurement, confounding measurement and account, and analysis. Data were tabulated and discussed in a narrative review. Each tumour type was looked at separately. Results: In all, 2425 potentially relevant articles were identified, of which 31 met the inclusion criteria. No study examined natural history alone. Seventeen studies reported retrospective data, 10 were prospective studies, and three were other study designs. There was one systematic review. There were no randomised controlled trials (RCTs). Approximately 5782 participants were included. Sample sizes ranged from 41 to 859. The age of participants ranged between 7 and 92 years. Types of cancers reported on were lung alone (n= 3), prostate alone (n= 6), breast alone (n= 7), mixed cancers (n= 13) and unclear (n= 1). A total of 93 prognostic factors were identified as potentially significant in predicting risk of SCC or collapse. Overall findings indicated that the more spinal metastases present and the longer a patient was at risk, the greater the reported likelihood of development of SCC and collapse. There was an increased risk of developing SCC if a cancer had already spread to the bones. In the prostate cancer studies, tumour grade, metastatic load and time on hormone therapy were associated with increased risk of SCC. In one study, risk of SCC before death was 24%, and 2.37 times greater with a Gleason score ≥ 7 than with a score of < 7 (p= 0.003). Other research found that patients with six or more bone lesions were at greater risk of SCC than those with fewer than six lesions [odds ratio (OR) 2.9, 95% confidence interval (CI) 1.012 to 8.35, p= 0.047]. For breast cancer patients who received a computerised tomography (CT) scan for suspected SCC, multiple logistic regression in one study identified four independent variables predictive of a positive test: bone metastases ≥ 2 years (OR 3.0 95% CI 1.2 to 7.6; p= 0.02); metastatic disease at initial diagnosis (OR 3.4, 95% CI 1.0 to 11.4; p= 0.05); objective weakness (OR 3.8, 95% CI 1.5 to 9.5; p= 0.005); and vertebral compression fracture on spine radiograph (OR 2.6, 95% CI 1.0 to 6.5; p= 0.05). A further study on mixed cancers, among patients who received surgery for SCC, reported that vertebral body compression fractures were associated with presurgery chemotherapy (OR 2.283, 95% CI 1.064 to 4.898; p= 0.03), cancer type [primary breast cancer (OR 4.179, 95% CI 1.457 to 11.983; p= 0.008)], thoracic involvement (OR 3.505, 95% CI 1.343 to 9.143; p= 0.01) and anterior cord compression (OR 3.213, 95% CI 1.416 to 7.293; p= 0.005). Limitations: Many of the included studies provided limited information about patient populations and selection criteria and they varied in methodological quality, rigour and transparency. Several studies identified type of cancer (e.g. breast, lung or prostate cancer) as a significant factor in predicting SCC, but it remains difficult to determine the risk differential partly because of residual bias. Consideration of quantitative results from the studies does not easily allow generation of a coherent numerical summary, studies were heterogeneous especially with regard to population, results were not consistent between studies, and study results almost universally lacked corroboration from other independent studies. Conclusion: No studies were found which examined natural history. Overall burden of metastatic disease, confirmed metastatic bone involvement and immediate symptomatology suggestive of spinal column involvement are already well known as factors for metastatic SCC, vertebral collapse or progression of vertebral collapse. Although we identified a large number of additional possible prognostic factors, those which currently offer the most potential are unclear. Current clinical consensus favours magnetic resonance imaging and CT imaging modalities for the investigation of SCC and vertebral fracture. Future research should concentrate on: (1) prospective randomised designs to establish clinical and quality-of-life outcomes and cost-effectiveness of identification and treatment of patients at high risk of vertebral collapse and SCC; (2) Service Delivery and Organisation research on magnetic resonance imaging (MRI) scans and scanning (in tandem with research studies on use of MRI to monitor progression) in order to understand best methods for maximising use of MRI scanners; and (3) investigation of prognostic algorithms to calculate probability of a specified event using high-quality prospective studies, involving defined populations, randomly selected and clearly identified samples, and with blinding of investigators. Funding: This report was commissioned by the National Institute for Health Research Health Technology Assessment Programme NIHR HTA Programme as project number HTA 10/91/01.
MeSH term(s)	Breast Neoplasms/pathology ; Female ; Humans ; Lung Neoplasms/pathology ; Male ; Neoplasm Metastasis/pathology ; Prostatic Neoplasms/pathology ; Risk Factors ; Spinal Cord Compression/etiology ; Spinal Fractures/etiology ; Spinal Neoplasms/complications ; Spinal Neoplasms/diagnosis ; Spinal Neoplasms/pathology ; Spinal Neoplasms/secondary
Language	English
Publishing date	2013-09-26
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
ZDB-ID	2006765-3
ISSN	2046-4924 ; 1366-5278
ISSN (online)	2046-4924
ISSN	1366-5278
DOI	10.3310/hta17420
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Article ; Online: Women's knowledge of and attitude towards disability in rural Nepal.

Simkhada, Padam P / Shyangdan, Deepson / van Teijlingen, Edwin R / Kadel, Santosh / Stephen, Jane / Gurung, Tara

Disability and rehabilitation

2013 Volume 35, Issue 7, Page(s) 606–613

Abstract: Purpose: What is perceived to be a disability is both culturally specific and related to levels of development and modernity. This paper explores knowledge and attitudes towards people with disabilities among rural women in Nepal, one of the poorer ... ...

Abstract	Purpose: What is perceived to be a disability is both culturally specific and related to levels of development and modernity. This paper explores knowledge and attitudes towards people with disabilities among rural women in Nepal, one of the poorer countries in South Asia. Method: Four hundred and twelve married women of reproductive age (aged 15-49 years), from four villages in two different parts of Nepal, who had delivered a child within the last 24 months preceding the study, completed a standard questionnaire. Results: The majority of the participants only considered physical conditions that limit function of an individual and are visible to naked eyes, such as missing a leg or arm, to be disability. Attitudes towards people with disability were generally positive, for example most women believed that disabled people should have equal rights and should be allowed to sit on committees or get married. Most respondents thought that disability could result from: (i) accidents; (ii) medical conditions; or (iii) genetic inheritance. Fewer women thought that disability was caused by fate or bad spirits. Conclusions: There is need to educate the general population on disability, especially the invisible disabilities. There is also a need for further research on disability and its social impact. Implications for rehabilitation: • There is need to educate the general population on disability, especially the invisible disabilities and its rehabilitation. There is also a need for further research on disability and its social impact.
MeSH term(s)	Adolescent ; Adult ; Cross-Sectional Studies ; Culture ; Disabled Children ; Discrimination (Psychology) ; Female ; Health Knowledge, Attitudes, Practice/ethnology ; Humans ; Middle Aged ; Mothers/psychology ; Nepal ; Rural Population ; Socioeconomic Factors ; Surveys and Questionnaires ; Young Adult
Language	English
Publishing date	2013-04
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1104775-6
ISSN	1464-5165 ; 0963-8288
ISSN (online)	1464-5165
ISSN	0963-8288
DOI	10.3109/09638288.2012.702847
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Article ; Online: Current treatments in diabetic macular oedema: systematic review and meta-analysis.

Ford, John Alexander / Lois, Noemi / Royle, Pamela / Clar, Christine / Shyangdan, Deepson / Waugh, Norman

BMJ open

2013 Volume 3, Issue 3

Abstract: Objectives: The aim of this systematic review is to appraise the evidence for the use of anti-VEGF drugs and steroids in diabetic macular oedema (DMO) as assessed by change in best corrected visual acuity (BCVA), central macular thickness and adverse ... ...

Abstract	Objectives: The aim of this systematic review is to appraise the evidence for the use of anti-VEGF drugs and steroids in diabetic macular oedema (DMO) as assessed by change in best corrected visual acuity (BCVA), central macular thickness and adverse events Data source: MEDLINE, EMBASE, Web of Science with Conference Proceedings and the Cochrane Library (inception to July 2012). Certain conference abstracts and drug regulatory web sites were also searched. Study eligibility criteria, participants and interventions: Randomised controlled trials were used to assess clinical effectiveness and observational trials were used for safety. Trials which assessed triamcinolone, dexamethasone, fluocinolone, bevacizumab, ranibizumab, pegaptanib or aflibercept in patients with DMO were included. Study appraisal and synthesis methods: Risk of bias was assessed using the Cochrane risk of bias tool. Study results are narratively described and, where appropriate, data were pooled using random effects meta-analysis. Results: Anti-VEGF drugs are effective compared to both laser and placebo and seem to be more effective than steroids in improving BCVA. They have been shown to be safe in the short term but require frequent injections. Studies assessing steroids (triamcinolone, dexamethasone and fluocinolone) have reported mixed results when compared with laser or placebo. Steroids have been associated with increased incidence of cataracts and intraocular pressure rise but require fewer injections, especially when steroid implants are used. Limitations: The quality of included studies varied considerably. Five of 14 meta-analyses had moderate or high statistical heterogeneity. Conclusions and implications of key findings: The anti-VEGFs ranibizumab and bevacizumab have consistently shown good clinical effectiveness without major unwanted side effects. Steroid results have been mixed and are usually associated with cataract formation and intraocular pressure increase. Despite the current wider spectrum of treatments for DMO, only a small proportion of patients recover good vision (≥20/40), and thus the search for new therapies needs to continue.
Language	English
Publishing date	2013-03-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2012-002269
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Article ; Online: The relative clinical effectiveness of ranibizumab and bevacizumab in diabetic macular oedema: an indirect comparison in a systematic review.

Ford, John A / Elders, Andrew / Shyangdan, Deepson / Royle, Pamela / Waugh, Norman

BMJ (Clinical research ed.)

2012 Volume 345, Page(s) e5182

Abstract: Objective: To indirectly compare the effectiveness of ranibizumab and bevacizumab in the treatment of diabetic macular oedema.: Design: Systematic review and indirect comparison.: Data sources: Medline (1996-September 2011), Embase (1996-September ...

Abstract	Objective: To indirectly compare the effectiveness of ranibizumab and bevacizumab in the treatment of diabetic macular oedema. Design: Systematic review and indirect comparison. Data sources: Medline (1996-September 2011), Embase (1996-September 2011), and the Cochrane Central Register of Controlled Trials (Issue 4, 2011). Selection criteria for studies: Randomised trials evaluating ranibizumab or bevacizumab in diabetic macular oedema with a common comparator and sufficient methodological similarity to be included within an indirect comparison were eligible for inclusion. Main outcome measures: The primary outcome was the proportion of patients with an improvement in best corrected visual acuity of more than two lines on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. Secondary outcomes included mean changes in best corrected visual acuity and in central macular thickness, and adverse events. Best corrected visual acuity was converted to logMAR units, a linear scale of visual acuity with positive values representing increasing visual loss. Indirect comparisons were done using Bayesian methods to estimate relative treatment effects of bevacizumab and ranibizumab. Results: Five randomised controlled trials with follow-up of 6-12 months and a common comparator (multiple laser treatment) were sufficiently similar to be included in the indirect comparison. Generally studies were small, resulting in wide credible intervals. The proportions of patients with an improvement in best corrected visual acuity of >2 lines were 21/77 participants (27%) for bevacizumab and 60/152 participants (39%) for ranibizumab (odds ratio 0.95 (95% credible interval 0.23 to 4.32)). The wide credible intervals cannot exclude a greater improvement, or worse outcome, for either drug. The mean change in best corrected visual acuity non-significantly favoured bevacizumab (treatment effect -0.08 logMAR units (-0.19 to 0.04)). The difference in mean change in central macular thickness was not statistically significant between ranibizumab and bevacizumab (treatment effect -6.9 μm (-88.5 to 65.4)). Conclusions: Results suggest no difference in effectiveness between bevacizumab and ranibizumab, but the wide credible intervals cannot exclude the possibility that either drug might be superior. Sufficiently powered, direct head to head trials are needed.
MeSH term(s)	Angiogenesis Inhibitors/therapeutic use ; Antibodies, Monoclonal, Humanized/therapeutic use ; Bayes Theorem ; Bevacizumab ; Diabetic Retinopathy/complications ; Humans ; Macular Edema/drug therapy ; Macular Edema/etiology ; Markov Chains ; Monte Carlo Method ; Ranibizumab ; Treatment Outcome ; Visual Acuity
Chemical Substances	Angiogenesis Inhibitors ; Antibodies, Monoclonal, Humanized ; Bevacizumab (2S9ZZM9Q9V) ; Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2012-08-13
Publishing country	England
Document type	Comparative Study ; Journal Article ; Review ; Systematic Review
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj.e5182
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Treatments for macular oedema following central retinal vein occlusion: systematic review.

Ford, John A / Clar, Christine / Lois, Noemi / Barton, Samantha / Thomas, Sian / Court, Rachel / Shyangdan, Deepson / Waugh, Norman

BMJ open

2014 Volume 4, Issue 2, Page(s) e004120

Abstract: Objectives: To review systematically the randomised controlled trial (RCT) evidence for treatment of macular oedema due to central retinal vein occlusion (CRVO).: Data sources: MEDLINE, EMBASE, CDSR, DARE, HTA, NHSEED, CENTRAL and meeting abstracts ( ... ...

Abstract	Objectives: To review systematically the randomised controlled trial (RCT) evidence for treatment of macular oedema due to central retinal vein occlusion (CRVO). Data sources: MEDLINE, EMBASE, CDSR, DARE, HTA, NHSEED, CENTRAL and meeting abstracts (January 2005 to March 2013). Study eligibility criteria, participants and interventions: RCTs with at least 12 months of follow-up assessing pharmacological treatments for CRVO were included with no language restrictions. Study appraisal and synthesis methods: 2 authors screened titles and abstracts and conducted data extracted and Cochrane risk of bias assessment. Meta-analysis was not possible due to lack of comparable studies. Results: 8 studies (35 articles, 1714 eyes) were included, assessing aflibercept (n=2), triamcinolone (n=2), bevacizumab (n=1), pegaptanib (n=1), dexamethasone (n=1) and ranibizumab (n=1). In general, bevacizumab, ranibizumab, aflibercept and triamcinolone resulted in clinically significant increases in the proportion of participants with an improvement in visual acuity of ≥15 letters, with 40-60% gaining ≥15 letters on active drugs, compared to 12-28% with sham. Results for pegaptanib and dexamethasone were mixed. Steroids were associated with cataract formation and increased intraocular pressure. No overall increase in adverse events was found with bevacizumab, ranibizumab, aflibercept or pegaptanib compared with control. Quality of life was poorly reported. All studies had a low or unclear risk of bias. Limitations: All studies evaluated a relatively short primary follow-up (1 year or less). Most had an unmasked extension phase. There was no head-to-head evidence. The majority of participants included had non-ischaemic CRVO. Conclusions and implications of key findings: Bevacizumab, ranibizumab, aflibercept and triamcinolone appear to be effective in treating macular oedema secondary to CRVO. Long-term data on effectiveness and safety are needed. Head-to-head trials and research to identify 'responders' is needed to help clinicians make the right choices for their patients. Research aimed to improve sight in people with ischaemic CRVO is required.
MeSH term(s)	Humans ; Macular Edema/drug therapy ; Macular Edema/etiology ; Randomized Controlled Trials as Topic ; Retinal Vein Occlusion/complications ; Retinal Vein Occlusion/drug therapy ; Visual Acuity
Language	English
Publishing date	2014-02-10
Publishing country	England
Document type	Journal Article ; Review ; Systematic Review
ZDB-ID	2599832-8
ISSN	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2013-004120
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Test accuracy of drug and antibody assays for predicting response to antitumour necrosis factor treatment in Crohn's disease: a systematic review and meta-analysis.

Freeman, Karoline / Taylor-Phillips, Sian / Connock, Martin / Court, Rachel / Tsertsvadze, Alexander / Shyangdan, Deepson / Auguste, Peter / Mistry, Hema / Arasaradnam, Ramesh / Sutcliffe, Paul / Clarke, Aileen

BMJ open

2017 Volume 7, Issue 6, Page(s) e014581

Abstract: Objective: To present meta-analytic test accuracy estimates of levels of antitumour necrosis factor (anti-TNF) and antibodies to anti-TNF to predict loss of response or lack of regaining response in patients with anti-TNF managed Crohn's disease.: ... ...

Abstract	Objective: To present meta-analytic test accuracy estimates of levels of antitumour necrosis factor (anti-TNF) and antibodies to anti-TNF to predict loss of response or lack of regaining response in patients with anti-TNF managed Crohn's disease. Methods: MEDLINE, Embase, the Cochrane Library and Science Citation Index were searched from inception to October/November 2014 to identify studies which reported 2×2 table data of the association between levels of anti-TNF or its antibodies and clinical status. Hierarchical/bivariate meta-analysis was undertaken with the user-written 'metandi' package of Harbord and Whiting using Stata V.11 software, for infliximab, adalimumab,anti-infliximab and anti-adalimumab levels as predictors of loss of response. Prevalence of Crohn's disease in included studies was meta-analysed using a random effects model in MetaAnalyst software to calculate positive and negative predictive values. The search was updated in January 2017. Results: 31 studies were included in the review. Studies were heterogeneous with respect to the type of test used, criteria for establishing response and loss of response, population examined and results. Meta-analytic summary point estimates for sensitivity and specificity were 65.7% and 80.6% for infliximab trough levels and 56% and 79% for antibodies to infliximab, respectively. Pooled results for adalimumab trough levels and antibodies to adalimumab were similar. Pooled positive and negative predictive values ranged between 70% and 80% implying that between 20% and 30% of both positive and negative test results may be incorrect in predicting loss of response. Conclusion: The available evidence suggests that these tests have modest predictive accuracy for clinical status; direct test accuracy comparisons in the same population are needed. More clinical trial evidence from test-treat studies is required before the clinical utility of the tests can be reliably evaluated.
MeSH term(s)	Adalimumab/blood ; Adalimumab/immunology ; Adalimumab/therapeutic use ; Antibodies/blood ; Crohn Disease/drug therapy ; Humans ; Infliximab/blood ; Infliximab/immunology ; Infliximab/therapeutic use ; Predictive Value of Tests ; Treatment Outcome ; Tumor Necrosis Factor-alpha/antagonists & inhibitors
Chemical Substances	Antibodies ; Tumor Necrosis Factor-alpha ; Infliximab (B72HH48FLU) ; Adalimumab (FYS6T7F842)
Language	English
Publishing date	2017-07-02
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Review ; Systematic Review
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2016-014581
Database	MEDical Literature Analysis and Retrieval System OnLINE

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